MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number	AE05ML
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "after firing, the clip jaw remained closed and could not be replaced to its original position." no patient harm or injury reported.The patient's status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit of ae05ml auto endo5 ml lot 73k2401026 for investigation.The serial number of the device is sn (b)(6).The returned sample was visually examined with and without magnification.The device was returned with the trigger engaged.One clip was observed to be partially loaded into the jaws and the jaws were closed.There was biological material observed on the device.Upon functional testing, the trigger was engaged, but the partially loaded clip did not load into the jaws.The jaws and trigger did reset.The trigger was engaged again, but the clip still did not load into the jaws and was then manually removed.The first clip was able to be correctly latched.The trigger was engaged a third time and a clip loaded into the jaws, but it did not open.The clip was able to latch upon full engagement of the trigger.The feeder tip was not observed upon the engagement of the clips.The device was disassembled.The appropriate amount of grease was observed on the ratchet area, and the trigger ears were not damaged.No damage was observed on the yoke assembly.During the disassembly, one clip was ejected from the jaws.The jaws and jaw assembly were undamaged and no tabs on the box or channel area were bent/damaged.Clips in the channel area were observed to be misaligned, but there was no clip stacking.11 clips were found remaining in the device, indicating the customer fired 4 clips.The feeder tip was observed to be broken off the feeder.The broken tip was not returned by the customer and could not be found anywhere in the device.The r & d team were consulted regarding this investigation.It was determined that the probable root cause of the misaligned clips and broken feeder tip break was user error or mishandling of the device.No other damage or defects were observed on the remaining components.The ifu for this product was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." clips were observed to be misaligned in the channel, and the tip of the feeder had been broken off.The r & d team were consulted regarding this investigation.It was determined that the probable root cause of the misaligned clips and feeder tip break was user error or mishandling of the device.The reported complaint of "jaws not opening completely" could be confirmed based upon the sample received.The returned sample was visually examined with and without magnification.The device was returned with the trigger engaged.One clip was observed to be partially loaded into the jaws and the jaws were closed.The ae05ml is 100% tested at the end of the assembly line.A system test fixture is utilized by manufacturing to verify proper function by latching 2 clips of every device on overstress silicone tubing.Indicating the damage occurred post-manufacturing, as the damage to the feeder tip would prevent the clips from loading properly.For these reasons, the probable root cause of this issue could not be conclusively linked to manufacturing.A dhr review was performed with no evidence to suggest a manufacturing related cause.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that "after firing, the clip jaw remained closed and could not be replaced to its original position." no patient harm or injury reported.The patient's status is reported as "fine".

• Brand Name: WECK AUTO ENDO5 ML
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24551411
• Report Number: 3003898360-2026-00109
• Device Sequence Number: 21178689
• Product Code: FZP
• UDI-Device Identifier: 14026704741868
• UDI-Public: (01)14026704741868(11)241101(17)260501(10)73K2401026(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K230480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Catalogue Number: AE05ML
• Device Lot Number: 73K2401026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown